Fixed Dose Combinations for Solid Oral Drug Delivery

  • ID: 4078509
  • Book
  • 400 Pages
  • John Wiley and Sons Ltd
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Fixed dose combinations (FDC) combine two or more active pharmaceutical ingredients (APIs) in a single dosage. They are increasingly popular and cost–effective treatment options, having demonstrated strong clinical efficacy. However, developing FDCs comes with a number of challenges: First, drug developers need to give careful consideration to the mechanisms of action of the APIs being considered for combination. Regulatory agencies have established guidance for industry regarding the development of FDC products, and they can be challenging to meet. In addition, there could be significant formulation and/or manufacturing problems when combining two or more APIs into a single dosage form.

To fill the need pharmaceutical scientists have when developing these drugs,Fixed Dose Combinations for Solid Oral Drug Delivery presents a systematic guide to this class of therapeutics. Chapters address various topics related to the clinical considerations, suitability of drug types and therapeutic categories, as well as successful formulation development and manufacturing of FDC products. The contributing authors who work on the frontlines of the global drug and regulatory industries include case studies to illustrate the best practices as well as challenges involved during development, manufacturing, and quality management.

Outlining the steps for developing FDC drugs, this book:

Deals with a growing part of the pharmaceutical industry, as FDCs are ideal for targeting many chronic illnesses and for reducing the number of medications an increasingly–aging population needs to take

    Ensures consistency in the delivery of FDC medication, which can be pivotal in increasing patient compliance and quality of life

    Collects dispersed knowledge from patents in addition to scientific and clinical literature   so researchers can access a single source reference

    Covers regulatory guidelines from around the world and looks ahead at developing areas of personalized medicine for FDCs
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Ali R. Rajabi–Siahboomi, PhD, is Vice President and Chief Scientific Officer at Colorcon. His main research interests are in the area of solid dosage form pharmaceutics and pharmaceutical technology with emphasis on oral drug delivery systems. He has published over 250 articles, book chapters, abstracts, and patents.


Amitava Mitra, PhD,
works in the Biopharmaceutics group at Merck Research Labs. His main research interests include pharmacokinetics, biopharmaceutics, and modeling and simulation of oral and alternate drug delivery systems. He has published more than 20 research and review articles in peer–reviewed journals and book chapters.
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